CATAFLAM 50

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Cataflam 50
50 mg, coated tablets
Diclofenacum kalicum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Cataflam 50 is and what it is used for
2. Important information before taking Cataflam 50
3. How to take Cataflam 50
4. Possible side effects
5. How to store Cataflam 50
6. Contents of the pack and other information

1. What Cataflam 50 is and what it is used for

Cataflam 50 contains diclofenac potassium, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It has anti-rheumatic, anti-inflammatory, analgesic, and antipyretic properties. The mechanism of action of Cataflam 50 involves inhibition of prostaglandin biosynthesis, which plays a key role in the pathogenesis of inflammation, pain, and fever.

Cataflam 50 is used for short-term treatment of the following acute conditions:

• Traumatic pain, inflammatory conditions, and swelling, e.g., following joint sprains.
• Postoperative pain, inflammation, and swelling, e.g., after dental or orthopedic procedures.
• Painful and (or) inflammatory conditions in gynecology, e.g., primary dysmenorrhea or adnexitis.
• Migraine attacks.
• Spinal pain syndromes.
• Extra-articular rheumatism.
• As an adjunctive treatment in severe painful ear, nose, or throat infections, e.g., pharyngitis or tonsillitis, otitis. According to general therapeutic principles, causal treatment should be applied first. Fever, when the only symptom of disease, is not an indication for administration of this medicine.

Monitoring during treatment with Cataflam 50
In patients with diagnosed heart disease or significant risk factors for heart disease, the treating physician should periodically assess the patient's need for symptomatic treatment and response to the medicine, especially if treatment lasts longer than 4 weeks.
Regular blood tests should be performed during treatment if there are any signs of liver function disorders, kidney function disorders, or blood abnormalities. Liver function (transaminase levels), kidney function (creatinine levels), and blood cell counts (white and red blood cells and platelets) should be monitored. The treating physician will consider the blood test results when deciding whether to discontinue treatment with Cataflam 50 or adjust the dosage.

2. Important information before using Cataflam 50

When not to use Cataflam 50:

• if the patient is allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6),
• if the patient has ever experienced an allergic reaction after taking anti-inflammatory or pain-relieving medicines (e.g. acetylsalicylic acid, diclofenac or ibuprofen). Reactions may include asthma, rhinitis, skin rash, swelling of the face, lips, tongue, throat and/or limbs (symptoms of angioedema), breathing difficulties, chest pain or any other allergic-type reactions. If the patient suspects they may be allergic, they should consult their doctor for advice,
• if the patient has active or a history of peptic ulcer disease of the stomach and/or duodenum, gastrointestinal bleeding or perforation; if the patient has previously experienced stomach discomfort or heartburn after taking anti-inflammatory medicines,
• if the patient is in the third trimester of pregnancy,
• if the patient has liver failure,
• if the patient has kidney failure,
• if the patient has heart disease and/or cerebrovascular disease, e.g. following myocardial infarction, stroke, mini-stroke (transient ischaemic attack), or arterial embolism in the heart or brain, or following a procedure to unblock or bypass blocked blood vessels,
• if the patient has existing or a history of circulatory disorders (peripheral vascular disease). Like other non-steroidal anti-inflammatory drugs (NSAIDs), Cataflam 50 should not be used in patients in whom administration of acetylsalicylic acid or other drugs inhibiting prostaglandin synthesis may trigger an asthmatic attack, urticaria or acute rhinitis.

Patients should inform their doctor if any of the above conditions apply.
Warnings and precautions
Before using Cataflam 50, discuss with your doctor:

• if the patient has diagnosed cardiovascular disease (see above) or significant risk factors such as high blood pressure, abnormally elevated blood lipid levels (cholesterol, triglycerides), or if the patient is a smoker. If the doctor decides to prescribe Cataflam 50, the dose must not exceed 100 mg per day if treatment lasts longer than 4 weeks,
• if the medicine is to be used in patients with a history of gastrointestinal ulcers or in elderly patients. Use of diclofenac may cause gastrointestinal bleeding, ulceration or perforation (which may be fatal). This risk may be particularly high when high doses of diclofenac are used. If any unusual gastrointestinal symptoms occur during treatment with Cataflam 50 (especially gastrointestinal bleeding), the medicine should be discontinued immediately and the patient should contact their doctor,
• if the patient has ulcerative colitis or Crohn's disease; diclofenac may worsen the course of the disease,
• if the patient suffers from asthma, allergic rhinitis, nasal mucosal swelling (e.g. due to nasal polyps), chronic obstructive pulmonary disease or chronic respiratory tract infections, they are more likely to experience an allergic reaction to diclofenac (worsening of asthma symptoms, Quincke's edema or urticaria). This warning also applies to patients allergic to other substances (e.g. those experiencing skin reactions, itching or hives). The medicine should be administered with particular caution (preferably under medical supervision),
• if the patient has impaired liver function; diclofenac may exacerbate the disease. The patient must strictly follow the doctor's recommendations regarding regular liver function tests,
• if the patient suffers from hepatic porphyria. Diclofenac may trigger an attack of porphyria.

Before taking diclofenac, the patient should inform their doctor:

• if they smoke,
• if they have diabetes,
• if they suffer from angina, thrombosis, hypertension, elevated cholesterol or elevated triglyceride levels.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".
The risk of adverse effects can be minimized by using the medicine at the lowest effective dose and for the shortest duration necessary.
The lowest effective dose of Cataflam 50 that relieves pain and/or swelling should be used, and only for as short a time as possible, to minimize the risk of adverse effects.
If at any time during treatment with Cataflam 50 the patient experiences symptoms suggesting heart or blood vessel problems, such as chest pain, shortness of breath, weakness or slurred speech, they should contact their doctor or emergency department immediately.
Use of diclofenac may, very rarely (especially at the beginning of treatment), cause life-threatening skin reactions (e.g. exfoliative dermatitis, Stevens-Johnson syndrome with widespread rash, high fever and joint pain, or toxic epidermal necrolysis with lesions on the skin and mucous membranes, high fever and severe general condition). At the first signs of rash, mucosal lesions or other symptoms of allergic reaction, the medicine should be discontinued and the patient should contact their doctor.
The medicine may mask symptoms of infection (e.g. headache, elevated body temperature) and may complicate accurate diagnosis. The patient should inform their doctor about using this medicine during medical examinations.
Cataflam 50 should not be used concomitantly with other systemic non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors.
Before using the medicine, the patient should inform their doctor or pharmacist about any of the above-mentioned conditions.
Use of medicines such as Cataflam 50 may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses.
Doses higher than recommended or longer treatment duration than advised should not be used.
If the patient has heart problems, has had a stroke, or suspects they may be at risk of such conditions (e.g. high blood pressure, diabetes, high cholesterol, smoking), they should consult their doctor or pharmacist about treatment options.
The medicine may transiently inhibit platelet aggregation.
Before taking Cataflam 50, the patient should inform their doctor if they have recently undergone or are scheduled for surgery of the stomach or gastrointestinal tract, as Cataflam 50 may sometimes impair intestinal wound healing after surgery.
Children and adolescents
Cataflam 50 should not be used in children and adolescents under 14 years of age. For children and adolescents under 14 years, diclofenac in suppository form at a dose of 25 mg daily is recommended. Cataflam 50 should not be used in children under 1 year of age.
Elderly patients (aged 65 years and above)
Elderly patients may be more sensitive to the effects of the medicine than younger adults. Patients should follow the instructions in the leaflet, use the lowest effective dose as recommended by their doctor, and report any adverse effects occurring during treatment to their doctor.
Cataflam 50 and other medicines
The patient should inform their doctor about all medicines currently or recently taken, as well as any medicines they plan to take.
The patient should especially inform their doctor if they are taking the following medicines:

• Lithium or medicines belonging to the group of antidepressants (Selective Serotonin Reuptake Inhibitors)
• Digoxin – a medicine used in the treatment of heart conditions
• Diuretics – medicines that increase urine output
• Angiotensin-converting enzyme inhibitors, beta-blockers – groups of medicines used in the treatment of hypertension and heart failure
• Non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid or ibuprofen) and corticosteroids (a group of medicines used to relieve inflammation in affected body areas)
• Anticoagulants and antiplatelet medicines
• Antidiabetic medicines, except insulin
• Methotrexate – a medicine used in the treatment of certain cancers or arthritis
• Cyclosporine and tacrolimus – medicines used in organ transplant recipients
• Trimethoprim – a medicine used to prevent and treat urinary tract infections
• Quinolone antibiotics – medicines used to treat infections
• Colestipol and cholestyramine – medicines that lower blood cholesterol levels
• Voriconazole – a medicine used to treat fungal infections
• Phenytoin – a medicine used to treat epileptic seizures

Taking Cataflam 50 with food and drink
Tablets should be swallowed whole with water, preferably before a meal.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine.
During pregnancy, Cataflam 50 should not be used during the first two trimesters unless absolutely necessary.
Like other anti-inflammatory medicines, Cataflam 50 should not be used during the last three months of pregnancy, as it may seriously harm the unborn child or adversely affect delivery.
Cataflam 50 should not be used by breastfeeding women, as it may have harmful effects on the infant.
The doctor will discuss with the patient the potential risks of using Cataflam 50 during pregnancy and breastfeeding.
Taking Cataflam 50 may make it more difficult to become pregnant. If the patient plans to become pregnant or has difficulty conceiving, she should inform her doctor.
Driving and operating machinery
The effect of Cataflam 50 on the ability to drive, operate machinery or perform other tasks requiring special attention is unlikely.
Cataflam 50 contains sucrose
Cataflam 50 film-coated tablets contain sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Cataflam 50

This medicine should always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Do not exceed the recommended doses. When using Cataflam 50 enteric-coated tablets for longer than a few weeks, regular medical check-ups are recommended to rule out any undetected adverse effects.
The general recommendation is to individualize the dose and use the lowest effective dose for the shortest possible duration.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.

Adults
The recommended initial dose is 100 mg per day up to 150 mg per day.
In milder cases, a dose of 75 mg to 100 mg per day is considered sufficient.
Tablets for oral administration. The total daily dose should be divided and administered in 2 to 3 doses, as applicable.
Do not exceed a daily dose of 150 mg.
In women with primary dysmenorrhea, the initial dose is 50 mg, taken at the onset of the first symptoms, followed by continued treatment with 50 mg administered up to three times daily for several consecutive days, as needed. If a dose of 150 mg per day does not provide sufficient pain relief over two to three consecutive menstrual cycles, the treating physician may recommend an initial dose of 100 mg and administration of up to 200 mg per day, divided into 2 to 3 doses during subsequent menstrual cycles. Do not exceed a daily dose of 200 mg.
In the treatment of migraine, the initial dose is 50 mg, to be taken at the onset of the first symptoms indicating an attack. If pain relief is not sufficient within 2 hours after the first dose, an additional 50 mg dose may be administered. If necessary, further 50 mg doses may be taken at intervals of 4 to 6 hours. Do not exceed a daily dose of 200 mg.

Use in children and adolescents
Due to the strength of the dose, Cataflam 50 is not recommended for children and adolescents under 14 years of age.
For children and adolescents under 14 years of age, diclofenac in suppository form at a dose of 25 mg per day is recommended.
In adolescents over 14 years of age, a dose of 75 mg to 100 mg per day, divided into 2 to 3 doses, is usually sufficient. Do not exceed the maximum daily dose of 150 mg.
Cataflam 50 must not be used in children and adolescents (under 18 years) for the treatment of migraine.

Elderly patients (aged 65 years and above)
This medicine should be used with caution in elderly patients. In elderly patients and those with low body weight, the lowest effective dose is recommended.

Method of administration
Tablets should be swallowed whole with water, preferably before a meal. Do not divide or chew the tablets.

How long to use Cataflam 50
Cataflam 50 should always be used as directed by your doctor.
If Cataflam 50 is used long-term, regular contact with your doctor is recommended to ensure that no adverse effects have occurred.
If in doubt about how long to use the medicine, consult your doctor or pharmacist.

Use of a higher than recommended dose of Cataflam 50
Overdose with Cataflam 50 does not produce characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or convulsions. In cases of significant poisoning, acute renal failure and liver damage may occur.
If an overdose is accidentally taken, contact your doctor, pharmacist, or go to the nearest hospital emergency department immediately.

Missed dose of Cataflam 50
If a dose is missed, take it as soon as you remember. However, if more than half of the time between two doses has passed, do not take the missed dose and take the next dose according to the previous dosing schedule. Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The frequency of adverse effects is estimated as follows:
very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data).
The adverse effects listed below include those observed with Cataflam 50 as well as those observed with other formulations of diclofenac, used either short-term or long-term.

Adverse effects:
Common

• headache, dizziness,
• nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, decreased appetite,
• increased aminotransferase activity,
• rash.

Uncommon

• myocardial infarction, heart failure, palpitations, chest pain.

Rare

• hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock),
• somnolence,
• asthma (including breathlessness),
• gastric mucosal inflammation, gastrointestinal bleeding, haematemesis, bloody diarrhoea, melaena,
• gastric and/or duodenal ulceration (with or without bleeding or perforation),
• hepatitis, jaundice, liver function disorders,
• urticaria,
• oedema.

Very rare

• thrombocytopenia (reduced platelet count), leukopenia (reduced number of white blood cells in peripheral blood), anaemia (including haemolytic and aplastic anaemia), agranulocytosis (deficiency of neutrophil granulocytes),
• angioedema (including facial swelling),
• disorientation, depression, insomnia, nightmares, irritability, psychotic disorders,
• paraesthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular accident (stroke),
• visual disturbances, blurred vision, double vision,
• tinnitus, hearing disturbances,
• palpitations, chest pain, heart failure, myocardial infarction,
• hypertension, vasculitis,
• pneumonia,
• colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis, Crohn's disease), constipation, oral mucositis (including ulcerative stomatitis), glossitis, oesophageal disorders, membranous stricture of the intestine, pancreatitis,
• fulminant hepatitis, hepatic necrosis, liver failure,
• bullous rash, exanthema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, alopecia, photosensitivity reactions, purpura, Schönlein-Henoch purpura, pruritus,
• acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

Not known

• concurrent occurrence of chest pain and allergic reactions (symptoms of Kounis syndrome).

Taking medicines such as Cataflam 50 may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Some people may experience other adverse effects while taking Cataflam 50.
If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.

If any of the following effects occur, stop taking Cataflam 50 immediately and contact your doctor:

• stomach discomfort, heartburn or upper abdominal pain,
• vomiting blood, blood in stool, blood in urine,
• skin problems such as rash or itching,
• wheezing or shortness of breath,
• yellowing of the skin or whites of the eyes,
• persistent sore throat or high body temperature,
• swelling of the face, feet or legs,
• severe migraine,
• chest pain associated with cough,
• mild painful cramps and abdominal tenderness beginning shortly after starting Cataflam 50, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of onset of abdominal pain (frequency not known - cannot be estimated from available data),
• chest pain which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Some adverse effects may be serious
These uncommon adverse effects may occur in 1-10 patients per 1,000, especially when high daily doses (150 mg) are used for a prolonged period

• sudden, constricting chest pain (symptoms of myocardial infarction or heart attack).
• breathlessness, difficulty breathing when lying down, swelling of feet or legs (symptoms of heart failure).

If Cataflam 50 is taken for longer than a few weeks, regular contact with a doctor is recommended to ensure that no adverse effects have occurred.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Cataflam 50

Keep the medicine out of the sight and reach of children.
Store below 30°C. Keep in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Cataflam 50 contains

• The active substance is diclofenac potassium. Each Cataflam 50 tablet contains 50 mg of diclofenac potassium.
• The other ingredients are: anhydrous colloidal silicon dioxide, calcium phosphate, magnesium stearate, maize starch, povidone K 30, sodium carboxymethyl starch.
  Coating ingredients: microcrystalline cellulose, titanium dioxide (E 171), iron oxide red (E 172), macrogol 8000, povidone K 30, sucrose, talc.

What Cataflam 50 looks like and contents of the pack
One pack contains 10 coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Portugal, the country of export:
Laboratório Normal - Produtos Farmacêuticos, Lda.
Avenida Professor Doutor Cavaco Silva, 10E
Taguspark 2740-255 Porto Salvo
Portugal
Manufacturer:
Novartis Farma - Produtos Farmacêuticos, S.A.
Avenida Professor Doutor Cavaco Silva, 10E
Taguspark 2740-255 Porto Salvo
Portugal
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in Portugal, the country of export: 4566196
Parallel import authorisation number: 141/22